{"id":1919951,"url":"https://alion.io/job/coopercompanies-design-quality-engineer-senior","title":"Design Quality Engineer Senior","company":{"id":2859488,"name":"CooperCompanies","domain":"coopercos.com","url":"https://alion.io/company/coopercos","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":78,"open_postings":15,"ghost_share":0,"stale_share":0.867,"repost_share":0,"time_to_fill_p50_days":22,"computed_at":"2026-10-23T05:54:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Costa Rica"],"countries":["CR"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":33000,"max_usd":74000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":7932},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-05T15:21:34Z","employer_posted_date":"2026-10-05","last_verified_at":"2026-10-23T01:44:28Z","board_verified":true,"closed_at":null,"days_open":17,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":17},"description":"CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people experience life’s beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.\nQuality RepresentationActively represent Quality function on product/process development teams.\nMentor other disciplines as needed in the Quality Engineering methodology.\nProvide guidance to Engineering staff and other personnel ensuring design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.\n\nSupplier EngagementManage supplier new tooling to ensure final components are qualified at the supplier and on time utilizing PPAP tool. \nParticipate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.\nSpecifies quality characteristics and inspection plans for components, subassemblies, and finished devices with Engineering Team.\n\nCAPAs/Non conformancesLead or participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.\nEvaluate and disposition nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.\n\nDesign Participate in design reviews to evaluate designs and help identify alternative design solutions.\nHands-on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.\nProvide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.\nContribute to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.\n\nV&VParticipate in the development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities.\nCreation, evaluation, and validation of product and process test methods.\nEvaluate test protocols and reports to ensure testing is sufficient to meet regulatory requirements and quality objectives.\n\nRiskIdentify and manage risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading Risk management efforts of the design process and working with design and management team on managing product and process risks.\n\nProcess ImprovementActively identify and lead opportunities for improvements across all cross functional departments. \nPromote continuous improvement in design control activities and use of quality tools with design team and other departments. \n\nRegulatoryComply with applicable FDA and international regulatory laws/standards and Cooper’s Code of Conduct.\nMaintain knowledge of current regulatory requirements and standards as they pertain to development and release of medical devices.\nRepresent Cooper as needed in FDA, notified body, internal, and other audits.\n\nPerform other duties as assigned.\nTravel:\nThis position may require 0-5% domestic and/or international travel.\n Knowledge, Skills and Abilities:\nKnowledge of applicable laws and regulations.\nIntermediate skills in Excel, Word and PowerPoint.Advanced skills preferred.\nAbility to read and understand highly technical material.\nProficient in reading and writing in English. \nSelf-motivated and committed to a team approach.\nKnowledge of ISO 13485 and ISO 14971\nStrong interpersonal, organizational and project management skills.\nStrong oral, presentation and technical writing skills.\nStrong decision-making skills, preferably across a broad spectrum of Quality Engineering responsibilities.\nExperience leading cross-functional teams in a medical device development environment.\nStrong analytical and problem-solving skills with attention to detail. Knowledge of statistics and how to apply, evaluate, and provide recommendations from data.\nWork Environment:\nProduction/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.\nOccasionally lift to 35 pounds.\nExperience:\n5+ years experience in Quality Engineering in the medical device industry. Experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above. \nExperience in medical devices, with knowledge in women’s health is preferred.\nEducation:\nBachelor’s Degree or higher in Science or Engineering (or related field).\nCertification in Quality Engineering (ASQ Certified Quality Engineer).","description_format":"text","description_chars":5566,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Women’s Health & Maternity"],"lifecycle":[{"event":"open","at":"2026-10-05T17:47:38Z"}],"visa":[],"liveness":{"score":44,"band":"fade","label":"Fading","p_open":1,"p_active":0.585,"p_room":0.75,"age_days":17,"expected_fill_days":22,"reasons":["conf:4","stale_co","velocity","win:late","comp:brand"],"computed_at":"2026-10-23T05:54:15Z"},"pay":null,"html_url":"https://alion.io/job/coopercompanies-design-quality-engineer-senior","json_url":"https://alion.io/job/coopercompanies-design-quality-engineer-senior.json","meta":{"generated_at":"2026-10-23T10:28:51Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":15919,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":2859488},"rest":"https://alion.io/mcp/rest/get_company?id=2859488"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcoopercompanies-design-quality-engineer-senior"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fcoopercompanies-design-quality-engineer-senior"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fcoopercompanies-design-quality-engineer-senior"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/coopercompanies-design-quality-engineer-senior\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcoopercompanies-design-quality-engineer-senior"}]}